The CoreValve System was designed to serve the clinical needs of the broadest range of patients with aortic stenosis. The valve's self-expanding frame provides controlled deployment, enabling physicians to accurately place the valve inside a patient's original valve, while conforming to the native annulus to provide a seal. The FDA approved the entire CoreValve platform - including the 23mm, 26mm, 29mm and 31mm size valves - all of which are delivered through the smallest commercially available TAVR delivery system (18Fr, or approximately 1/4 inch), making it possible to treat patients with difficult or small vasculature.

"It's rewarding that we can now offer this life-saving therapy to patients at increased risk for surgery," said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic Structural Heart Business. "There is a lot of excitement among U.S. heart teams for the CoreValve System's high risk approval, and its unique design that leads to the clinical outcomes seen in the High Risk Trial. We will continue to safely introduce CoreValve System to these physicians, supporting heart teams through comprehensive training and education, imaging and patient evaluation programs."


Medtronic worked closely with the FDA throughout the pivotal clinical trial and Pre-Market Approval (PMA) review process. FDA granted Priority Review Designation for both the Extreme Risk and High Risk PMA submissions. Priority designation is granted to new therapies of major public health interest. Based on the strength of the trial data, FDA determined that sufficient information was available to evaluate the safety and efficacy of the Medtronic CoreValve System for both patient groups without the need for external Advisory Committee panels. This milestone, along with the priority review designation, accelerated regulatory approvals for the life-saving device.

The CoreValve System was approved by the FDA for patients at extreme risk in January 2014. Since receiving CE (Conformité Europé Mark in 2007, the CoreValve System has been implanted in more than 60,000 patients in more than 60 countries.

For more information about the CoreValve System, call 877-526-7890 or go to www.corevalve.com.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

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